FDA 510(k)

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems

Número K: K203537 · 2021-02-01

Data da decisão2021-02-01

Código do produtoKPR

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2021-02-01 under 510(k) number K203537. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems?

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems is a medical device that received FDA 510(k) clearance on 2021-02-01. The listed applicant is Sedecal., Sa.. The 510(k) number is K203537.

When did Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems receive FDA 510(k) clearance?

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems received FDA 510(k) clearance on 2021-02-01, under 510(k) number K203537.

Who is the listed applicant for Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems?

The FDA 510(k) record lists Sedecal., Sa. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems?

The FDA product code for Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems is KPR.

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Fonte oficial

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